Melbourne, Australia
NCT Number: NCT01540539
Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers
The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
- Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)
Exclusion criteria
Exclusion criteria
include, but are not limited to the following:
- Any illness or condition that would adversely affect the subject's participation in this study
- Any clinically significant abnormalities observed during the screening visit
- Use of certain medications taken before the screening visit
- Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
- Hospitalization within 60 days of the screening visit
- Any condition that would place the subject at risk, interfere with participation in the study
- History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- History of certain other conditions
- Positive urine, drug or alcohol screen result at screening
- Known sensitivity to any of the components of the investigational product formulation
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
- Live/attenuated vaccinations within 12 weeks of screening or during the study
Treatment and study plan
REGN1154 or placebo
DrugParticipants will receive active drug or placebo
Primary outcomes
-
Total number and severity of TEAEs
Time frame: Day 1 through Day 113
TEAEs (Treatment-emergent adverse events)
Secondary outcomes
-
Serum concentration
Time frame: Day 1 through Day 113
Serum concentrations of REGN1154 over time
-
Presence or absence of antibodies
Time frame: Day 1 through Day 113
Presence or absence of antibodies against REGN1154 over time.
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 28, 2012
- Registry last updated
- Jan 24, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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